Label: SKINGUARD RESTORE MOUSSE- chlorhexidine gluconate, climbazole, phytosphingosine salicyloyl liquid
- NDC Code(s): 50386-1350-1
- Packager: Vicar Operating Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 19, 2017
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DESCRIPTION
SkinGuard® Restore Mousse
Soap-free mousse with anti-bacterial and anti-fungal properties
ACTIVE INGREDIENTS: Chlorhexidine Gluconate 3%, Climbazole 0.5%, Phytosphingosine Salicyloyl 0.05%
INACTIVE INGREDIENTS: Water, Polysorbate 80, Propylene Glycol, Benzyl Alcohol, Laureth-23, Poloxamer 184, Fragrance.
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INDICATIONS & USAGE
INDICATIONS: For use on dogs and cats only. For the management of skin infections that are responsive to chlorhexidine and climbazole.
DIRECTIONS FOR USE: Shake well before use.
For localized application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the targeted area. Massage into the skin until fully penetrated. Do not rinse. Let air dry. Once dry, brush the hair coat again.
For whole body application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as many times as necessary to cover the whole body, avoiding areas around the eyes and mouth. Do not rinse. Let air dry. Once dry, brush the hair coat again.
Dosage:
Under 11 lbs: 1 pump per 2 lbs
11-88 lbs: 1 pump per 4 lbs
Over 88 lbs: 1 pump per 6 lbs
Dosage can be doubled for long-haired breeds.
Apply every 3 days for 2 to 3 weeks or as directed by your veterinarian. May be used as part of a management plan as recommended by your veterinarian.
- PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 mL BOTTLE LABEL
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INGREDIENTS AND APPEARANCE
SKINGUARD RESTORE MOUSSE
chlorhexidine gluconate, climbazole, phytosphingosine salicyloyl liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1350 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 30 mg in 1 mL SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL CLIMBAZOLE (UNII: 9N42CW7I54) (CLIMBAZOLE - UNII:9N42CW7I54) CLIMBAZOLE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50386-1350-1 200 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/06/2017 Labeler - Vicar Operating Inc. (052503799) Registrant - Ceva Sante Animale (261126049)